Avis De Sécurité sur Discovery MR750w 3.0T, Discovery MR750 3.0T, SIGNA PET / MR 3.0T, SIGNA HDxt 3.0T, SIGNA HDx 3.0T, SIGNA HD 3.0T, SIGNA Excite 3.0T and SIGNA 3.0T

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par GE Healthcare.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date
    2015-09-07
  • Pays de l'événement
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    Ge healthcare has recently been briefed on a potential security issue with head or neck imaging with discovery mr750w 3.0t, discovery mr750 3.0t, signa pet / mr 3.0t, signa hdxt 3.0t, signa hdx 3.0t, signa hd 3.0t, signa excite 3.0t and signa 3.0t. the currently displayed sar may be lower than the actual sar of head as predicted by sar modeling. the predicted sar head value from the modeling indicates that the actual sar value could be for some images exceeded the iec60601-2-33 limit of 3.2 w / kg. .

Manufacturer